Method of implanting a penile prosthetic in treating erectile dysfunction

ABSTRACT

A method of implanting a penile prosthetic in treating erectile dysfunction is described. The method includes providing a pump having a pump bulb including a mid-section having a first face that is planar in longitudinal cross-section and a second face that is concave and arced in longitudinal cross-section. The method includes implanting an inflatable member into a penis; implanting a reservoir into an abdomen; intraoperatively coupling the pump between the inflatable member and the reservoir; and implanting the pump in a scrotum.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes an inflatable cylinder that isimplanted in each corpora cavernosum of the penis, a reservoir implantedin the abdomen that communicates with the cylinders, and a pump, oftenlocated in the scrotum, that is employed to move liquid from thereservoir into the cylinders for inflation of the implanted cylinders.

In a typical application, the user squeezes a bulb of the pump multipletimes to draw liquid out of the reservoir and pump the liquid into thecylinders. The repeated squeezing of the bulb thus moves the liquid fromthe reservoir into the cylinders to provide the user with an erectpenis. The user may return the penis to its flaccid state by selectivelytransferring the liquid from the cylinders back into the reservoir.

Some users suffer from a reduced range of motion in their fingers orfrom reduced dexterity, at times due to arthritis of the hand. Theseusers can have difficulty in grasping the pump bulb or in repeatedlysqueezing the pump bulb.

Penile prostheses have proven effective in relieving erectiledysfunction in men. However, users and their surgeons would welcomeimprovements to penile prostheses.

SUMMARY

Aspects of the disclosure provide an implantable penile prostheticincluding a pump according to the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated, as they become betterunderstood by reference to the following detailed description. Theelements of the drawings are not necessarily to scale relative to eachother. Like reference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of an implantable penileprosthetic including a pump attached to inflatable penile inserts and areservoir.

FIG. 2 is a perspective view of one embodiment of the pump illustratedin FIG. 1.

FIG. 3A is a top view of one embodiment of the pump illustrated in FIG.1 and indicating the location of a longitudinal cross-sectional view ofFIG. 4.

FIG. 3B is a side view of one embodiment of the pump illustrated in FIG.1 and indicating the location of a lateral cross-sectional view of FIG.7.

FIG. 3C is an end side view of one embodiment of the pump illustrated inFIG. 1.

FIG. 4 is a schematic, longitudinal cross-sectional view taken along theline IV-IV in FIG. 3A.

FIG. 5 is a side view of one embodiment of the pump including a pumpbulb.

FIG. 6 is a partially sectional top view of the bulb of the pump takenalong the line V-V indicated in FIG. 5.

FIG. 7 is a lateral cross-sectional view of one embodiment of the pumpbulb taken along the line VII-VII in FIG. 3B.

FIG. 8 is a side view of one embodiment of the pump seen from a sidefacing opposite the side visible in FIG. 5.

FIG. 9A is an enlarged, schematic cross-sectional view of one embodimentof a transition area of the pump bulb.

FIG. 9B is an enlarged, schematic cross-sectional view of one embodimentof a transition area of the pump bulb.

FIG. 10 is a perspective view of one embodiment of a pump suitable foruse with the penile prosthetic illustrated in FIG. 1.

FIG. 11 is a schematic, perspective view of the pump bulb with a portionof the pump bulb cut away.

FIG. 12 is a longitudinal cross-sectional view of one embodiment of apump suitable for use with the penile prosthesis system shown in FIG. 1.

FIG. 13 is a perspective view of a hand accessing a finger gripping areaon one embodiment of a pump bulb.

FIG. 14 is a schematic view of one embodiment of the implantable penileprosthetic system of FIG. 1 implanted in a user.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” as employed in this application means that thereferenced part is situated next to or near the point of attachment ororigin or a central point: as located toward a center of the human body.The term “distal” as employed in this application means that thereferenced part is situated away from the point of attachment or originor the central point: as located away from the center of the human body.A distal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. Forexample, the glans penis is located distal, and of the crus of the penisis located proximal relative to the male body such that a distal end ofa corpora cavernosum of the patient extends about midway into the glanspenis.

Embodiments provide an implantable penile prosthetic including a pumpthat is provided with a pump bulb that is easier to grasp and easier topump, particularly for those users who suffer from arthritis or limiteddexterity of the hand. Embodiments provide a pump having a pump bulbincluding first and second end sections, each formed as a portion of asphere, a planar mid-section extending between the first end section andthe second end section and a concave portion extending between a firstapex located in the first end section and a second apex located in thesecond end section. The concave portion provides a finger access area toconfigure the pump bulb to more naturally fit in the hand between thefingers of the user.

Embodiments provide a pump having a pump bulb with an internal cavitydefined by an external surface, the external surface having sixinterconnected segments including a side segment forming a concavity.

In contrast, some implantable penile prosthetics are provided with acompletely spherical pump bulb that operates to pump liquid from theprosthetic reservoir to the penile implants. However, some users haveexperienced sliding and movement of the completely spherical pump bulbwithin the tissue of the scrotum that presents challenges in graspingand/or repeatedly pumping the completely spherical pump bulb. The pumpbulb described below includes a concave portion extending between afirst apex located in the first end section and a second apex located inthe second end section providing an improved finger-grasping surfacewith an easier to manipulate pump, particularly for users with limiteddexterity.

FIG. 1 is a perspective view of one embodiment of an implantable penileprosthetic 20. The penile prosthetic 20 includes a reservoir 22communicating with inflatable members 24 across a pump 26. The reservoir22 is connected with the pump 26 by tubing 28, and inflatable members 24are connected with the pump 26 by tubing 30.

The components (reservoir 22, implants 24, pump 26, and tubing 28, 30)of the penile prosthetic 20 are generally provided unassembled in a kitof parts. The components are assembled immediately prior to surgery, orintra-operatively, as determined by the surgeon. For example, each ofthe tubing lengths 28, 30 have a portion that is attached to thereservoir 22 and a portion that is attached to the inflatable members24, respectively, and a portion that is secured to a pump housing 40that extends from a pump bulb 42 of the pump 26. The tubing lengths areattached by some form of tubing connector useful with surgical implants.The components of the penile prosthetic 20 are illustrated in anassembled configuration in FIG. 1 for descriptive clarity.

The reservoir 22 is sized for implantation within the human body, forexample within the abdomen. The reservoir 22 is configured to retain avolume of liquid useful in inflating the inflatable members, for examplewith a volume in a range of 50-350 cc. Suitable materials forfabricating the reservoir 22 include silicone, polymers such asurethanes, a blend of polymers with urethane, copolymers of urethane, orthe like. In one exemplary fabrication process, one of the suitablematerials identified above is moulded into a container shape appropriatefor implantation in the space of Retzius or in the abdomen.

The inflatable members 24 are provided as a pair of inflatablecylinders, each of which is sized to be implanted into a corporacavernosum of the penis. Each of the cylinders includes a rear tip thatis implanted toward the crus of the penis and a distal end that isimplanted within the glans penis. The cylinders are fabricated frommaterial configured to collapse and be flexible when the cylinders aredeflated to provide the penis with a flaccid state and expand when thecylinders are inflated with liquid to provide the penis with an erectstate. Suitable material for fabricating the cylinders 32 includessilicone, polymers such as urethanes, a blend of polymers with urethane,copolymers of urethane, or the like. Suitable cylinders are availablefrom Coloplast Corp., Minneapolis, Minn.

FIG. 2 is a perspective view of the pump 26 according to one embodiment.

In one embodiment, the pump housing 40 is attached to the pump bulb 42and includes valve assemblies (described below) in communication withconduits that extend from the pump housing 40 for attachment with thetubing 28, 30. The valve assemblies facilitate controlling of the fluidto inflate and deflate the cylinders 32, respectively.

The pump bulb 42 includes a first end section 50 and a second endsection 52. Each one of the first end section 50 and the second endsection 52 is formed as a portion of a sphere. It is to be understood bythe wording “portion of a sphere” that each of the first end section 50and the second end section 52 is configured to provide a surface of thepump bulb 42 formed as a portion of the surface of a sphere. The pumpbulb 42 includes a mid-section 54 that is extending between the firstend section 50 and the second end section 52. The mid-section 54 isplanar when seen in longitudinal cross-section through the pump bulb 42(FIGS. 3A, 4). The mid-section 54 forms an arc 56 when seen in lateralcross-section through the pump bulb 42 (FIGS. 3B, 7). In one embodiment,the arc 56 is a circular arc. The pump bulb 42 includes a concaveportion 58 extending between a first apex 60 located in the first endsection 50 and a second apex 62 located in the second end section 52. Inone embodiment, the second end section 52 is attached to the pumphousing 40. In one embodiment, the pump bulb 42 is monolithically formedwith the pump housing 40 at the second end section 52.

FIG. 3A is a schematic top view of the pump 26 indicating the positionof the longitudinal cross-section through the pump bulb 42 of FIG. 4.

FIG. 3B is a schematic side view of the pump 26 indicating the positionof the lateral cross-section through the pump bulb 42 of FIG. 7.

FIG. 3C is an end view of the pump 26 seen from an end opposite thelocation of the pump bulb 42 and indicating the tubing 28, 30.

FIG. 4 is a schematic, longitudinal cross-sectional view taken along theline IV-IV in FIG. 3A illustrating an overall contour of the pump andpump bulb.

In FIG. 4, the mid-section 54 has a planar extent extending between thefirst end section 50 and the second end section 52. The planarmid-section 54 is connected between the spherical portions for the firstand second end sections 50, 52. It is to be understood that the planarextent of mid-section 54 means that an external surface 64 of themid-section 54 extends parallel with a longitudinal axis A-A through thepump 26. The mid-section 54 is planar when seen in longitudinalcross-section through the pump bulb 42. In other words, the externalsurface 64 of the pump bulb 42 along the mid-section 54 is parallel tothe axis A-A when seen in longitudinal cross-section through the pumpbulb 42. The external surface 64 of the mid-section 54 is planar andtakes the shape of a straight line between the first and second endsections 50, 52 when seen in longitudinal cross-section through the pumpbulb 42. The second end section 52 of the pump bulb 42 is attached tothe pump housing 40. The tubing 28, 30 extends from the pump housing 40.

FIG. 5 is a schematic side view of the pump 26 also indicating theposition of the partially sectional top view of FIG. 6 taken along lineVI-VI.

In FIG. 6, a portion of the pump 26 including the housing 40 and thetubing 28, 30 is viewed in a regular top view and a portion includingthe pump bulb 26 in shown at a section line through the pump bulb 26 toillustrate sections of the pump bulb 26.

FIGS. 5 and 6 show the first and second end sections 50, 52 and themid-section 54. As in FIG. 4, the side view of FIG. 5 also shows themid-section 54 with the planar external surface 64 extending between thefirst end section 50 and the second end section 52. FIG. 6 shows a firstconcave portion 58 a extending between the first apex 60 located in thefirst end section 50 and the second apex 62 located in the second endsection 52. In one embodiment (as illustrated in FIG. 6), the pump bulb42 includes a second concave portion 58 b extending between a third apex66 located in the first end section 50 and a fourth apex 68 located inthe second end section 52. The second concave portion 58 b is separatefrom the first concave portion 58 a. In one embodiment, the firstconcave portion 58 a and the second concave portion 58 b are located onopposite sides of the pump bulb 26, with the mid-section 54 connectedbetween the first concave portion 58 a and the second concave portion 58n. In one embodiment, the first concave portion 58 a and the secondconcave portion 58 b face in opposite directions of each other inrelation to the longitudinal A-A through the pump 26. This configurationof the concave portions 58 a, 58 b helps provide easier tactilerecognition of the concave portions 58 a, 58 b of the pump bulb 42through a skin surface when the user is looking to locate the grippingsurfaces for engagement of the pump to create an erection of the penis.

In one embodiment, a first width W1 of the pump bulb 42 between anexternal surface of the concave portion 58 a and an external surface ofthe concave portion 58 b is greater than a second width W2 of the pumpbulb 42 between planar extent surfaces 64 of the mid-section 54. In oneembodiment, the pump bulb is configured such that width W2 is smallestbetween a vertex 70 a of the concave portion 58 a and a vertex 70 b ofthe concave portion 58 b.

In embodiments, a first longitudinal extent L1 of the mid-section 54 isshorter than a second longitudinal extent L2 of a concave portion 58 a,58 b between the first apex 60 and the second apex 62, and/or betweenthe third apex 66 and the fourth apex 68, respectively. In other words,in embodiments the longitudinal extent of the mid-section 54 isdifferent from a longitudinal extent of the concave portion 58 measuredbetween respective apices.

FIG. 7 is a lateral cross-sectional view of one embodiment of the pumpbulb 42 taken along the line VII-VII in FIG. 3B. The cross-sectionalview is located at the mid-section 54 of the pump bulb 42. In oneembodiment, a boundary of the mid-section 54 is formed by a plurality ofdiscrete segments 55, 57. In embodiments, each segment 55, 57 of aplurality of discrete segments forms an arc 56 in lateral cross-section.In embodiments, the plurality of discrete segments combine to configurethe mid-section 54 to form an arc in lateral cross-section. In oneembodiment, the mid-section 54 includes two discrete segments 55, 57each forming a circular arc 56 a, 56 b. In the cross-section of FIG. 6,the circular arc 56 a has a curved extent between the first concaveportion 58 a and the second concave portion 58 b. The circular arc 56 a,56 b defines a curve in the plane of the paper. In one embodiment, themid-section 54 includes a first arc-shaped segment 55 and a secondarc-shaped segment 57, each of the first and the second arc-shapedsegment 55, 57 extending between the first concave portion 58 a and thesecond concave portion 58 b. FIG. 7 also shows an internal surface 51 ofthe first end section 50 (to be understood as bulging away from theobserver and away from the plane of the paper). Also visible is thefirst apex 60 and the third apex 66. In embodiments, the concaveportions 58 a, 58 b are adapted to form a finger gripping (or grasping)area of the pump bulb 42. In one embodiment, the concave portions 58 a,58 b include a friction-increasing surface 72, such as, but not limitedto a criss-cross surface pattern. FIG. 7 also indicates an internalcavity 74 of the pump bulb 42. The internal cavity 74 is defined(surrounded) by the first and second end sections 50, 52, the first andsecond arc-shaped segments 55, 57 and the first and second concaveportions 58 a, 58 b.

In one embodiment, the pump bulb 26 includes a second concave portion 58b separate from the first concave portion 58 a, wherein the mid-section54 includes a band that is connected between the first concave portion58 a and the second concave portion 58 b, and the band is narrower thana width of either of the first concave portion 58 a and the secondconcave portion 58 b.

In embodiments, the concave portion 58 is bounded by a first curved linelocated in the first end section 50 and a second curved line located inthe second end section 52, where the concave portion 58 and the firstand second curved lines form a finger gripping area of the pump bulb 26.

In one embodiment, the concave portion 58 has a boundary provided by afirst curved line located in the first end section 50, a second curvedline located in the second end section 52, and a pair of separated andparallel linear lines connected between the first curved line located inthe first end section 50 and the second curved line located in thesecond end section 52.

The concave portions 58 a, 58 b are each sized to receive a thumb or afinger of the user. The distinct difference of the surfaceconfigurations of the concave portion 58 a, 58 b and the sphere shape ofthe first and second end sections 50, 52 provides a pump bulb 42 whereinthe grasping surfaces provided by the concave portions 58 a, 58 b areeasily located by the user when he palpates the skin surface of thescrotum. Contrary to the case of some prostheses incorporatingcompletely spherical pump bulbs, each of the concave portions 58 a, 58 bof the pump bulb 42 provides a rest for the user's thumb or otherfinger, which helps stabilize the pump 26 and further helps prevent thepump bulb 42 from unintentionally slipping out between the fingers ofthe user. Each of the first and second end sections 50, 52 is sized andconfigured to provide a wide obstacle that helps resist slipping throughthe user's fingers when the user squeezes the concave portions 58 a, 58b of the pump bulb 42. In this manner, the pump bulb 42 has increasedstability during compression compared to a completely spherical bulb andis therefore easier to use and squeeze for those who suffer fromarthritis and limited dexterity.

Moreover, the increased stability of the pump bulb 42 helps facilitateuse of less force for squeezing and engaging the pump bulb 42 and thisadditionally means that the user's overall tactile perception of thepumping procedure is improved. Improved stability and a reduction of therequired squeezing force of the pump bulb 42 is particularly, but notexclusively, useful when the user is familiarizing himself with thepenile prosthesis in the period following healing and initially learningto apply pressure to the pump bulb 42. Even further, squeezing ofoppositely facing concave portions 58 a, 58 b delivers an increased andmore effective evacuation force as compared to completely spherical pumpbulbs, and this makes squeezing of the pump bulb 42 more efficient indelivering liquid to the cylinders 24.

In embodiments, the disclosure relates to an implantable penileprosthetic having a pump 26 including a pump bulb 42 having an internalcavity formed by an external surface including six interconnectedsegments. It is to be understood that the term “interconnected” is notintended to imply that each individual segment is necessarily connectedto each and all of the other five segments. Instead, the six segmentscombine to define an internal cavity of the pump bulb such that the pumpbulb is capable of holding liquid in the internal cavity during apumping action.

With reference to FIGS. 4-7, in one embodiment the pump bulb 42 includesa top segment 50 formed as a portion of a top sphere surface, with acentre of the top sphere surface offset away from a centre 76 of theinternal cavity 74. The pump bulb 42 includes a bottom segment 52 formedas a portion of a bottom sphere surface, with a centre of the bottomsphere surface offset away from the centre 76 of the internal cavity 74.The pump bulb 42 includes a first arc-shaped side segment 55 and asecond arc-shaped side segment 57, each of the side segments 55, 57connecting the top segment 50 with the bottom segment 52. The pump bulb42 includes a third side segment 58 a shaped as a portion of a sphereand a fourth side segment 58 b shaped as a portion of a sphere. Each ofthe third and fourth side segments 58 a, 58 b connects the top segment50 with the bottom segment 52 such that the external surface at thethird side segment 58 a and the fourth side segment 58 b defines aconcavity.

FIG. 8 is a side view of one embodiment of a pump 26 including a pumpbulb 42. In one embodiment, the first arc-shaped side segment 55 isconnected to the top segment 50 along a first curved line 78 and to thebottom segment 52 along a second curved line 80. The second arc-shapedside segment 57 is connected to the top segment 50 along a third curvedline 82 and to the bottom segment 52 along a fourth curved line 84.

In one embodiment, the first arc-shaped side segment 55 is connected tothe third side segment 58 a along a first straight line 86 and to thefourth side segment 58 b along a second straight line 88 (see FIG. 5).The second arc-shaped side segment 57 is connected to the third sidesegment 58 a along a third straight line 90 and to the fourth sidesegment 58 b along a fourth straight line 92 (see FIG. 5).

In one embodiment, the third side segment 58 a is connected to the topsegment 50 along a fifth curved line 94 and to the bottom segment 52along a sixth curved line 96. The fourth side segment 58 b is connectedto the top segment 50 along a seventh curved line 97 and to the bottomsegment 52 along an eighth curved line 98 (see FIG. 5).

In embodiments, the pump bulb 42 includes a transition area 99 a-99 h(FIG. 8), 99 i-99 l (FIG. 5) between any two adjacent segments 50, 52,55, 57, 58 a, 58 b. In embodiments, this is advantageous in that ithelps provide clearly defined and differentiated segments, in turnaiding in tactile recognition of the relevant gripping surfaces of thepump bulb 42 through the skin surface after implantation of theprosthesis. Moreover, the transition area 99 a-99 i helps provide asmooth, edge-or ridge-free surface of the pump bulb 42 for implantation.

In one embodiment, the transition area 99 a-99 l is defined by a planesurface, i.e. the transition area extends along a straight line betweentwo neighbouring segments. In one embodiment, the transition area 99a-99 l is defined by a curved surface, i.e. the transition area extendsalong an arc between two neighbouring segments.

FIG. 9A is an enlarged, schematic view of one exemplary transition area,in this example transition area 99 b between second side segment 57 andthird side segment 58 a. In FIG. 9A the transition area 99 b is definedby a plane surface, i.e. the transition area extends along a straightline between intersection point P at third side segment 58 a andintersection point Q and the second side segment 57.

FIG. 9B is a schematic view of exemplary transition area 99 b in oneembodiment wherein the transition area is defined by a curved surface,i.e. the transition area extends along an arc between intersection pointP at third side segment 58 a and intersection point Q and the secondside segment 57.

In embodiments, the pump bulb 42 includes intersection points betweenthree neighbouring segments wherein the transition area can curve inmore than one dimension, or can include a polygonal surface area definedby more than one straight line. Such intersection point configurationsare advantageous in that they provide a smooth transition betweenmultiple segments having differentiated external surfaces.

In one embodiment, the disclosure provides a pump bulb 42 having afinger pad 58 a, 58 b extending between four segments 50, 52, 55, 57. Inone embodiment, the disclosure provides a pump bulb 42 including afinger gripping area in a concavity 58 a, 58 b defined by four segments50, 52, 55, 57.

FIG. 10 is a perspective view of one embodiment of a pump 26 suitablefor use with the penile prosthetic illustrated in FIG. 1. The pump 26includes a pump housing 40 and a pump bulb 42. The housing 40 holds oneor more valves that control the flow of liquid out of the pump bulb 42.In one embodiment, the pump bulb 42 is attached to the pump housing 40such that the external surface of each of the segments 58 a, 58 b facetowards a plane that is parallel with another plane including anactivation surface 168 on the pump housing 40 (as shown in FIG. 10). Inother embodiments, the pump bulb 42 is attached to the pump housing 40such that the external surface of each of the segments 58 a, 58 b facetowards a plane that is perpendicular to another plane including theactivation surface 168 on the pump housing 40. In other words, the pumpbulb 42 can be attached such that it is rotated 90 degrees in relationto the pump housing 40. Examples of this embodiment are shown in FIGS. 6and 8. The specific configuration of the attachment of the pump bulb 42to the pump housing 40 can be adjusted according to parameters such as,but not exclusively, patient anatomy and the preferred surgicalprocedure for the implantation.

The pump bulb 42 has an internal cavity 74 (schematically indicated withpunctured line in FIG. 10) that is defined (surrounded) by sixinterconnected segments 50, 52, 55, 57, 58 a, 58 b (segments 57 and 58 bnot visible in FIG. 10). The six interconnected segments form an outercircumference of the pump bulb 42. The pump bulb 42 forms two fingerpads located at the external surface of the side segments 58 a, 58 b.Each finger pad is spaced apart from the other finger pad by thesegments 50, 52, 55 and 57.

FIG. 11 is a schematic, perspective view of the pump bulb 42 with aportion of the pump bulb cut away for better illustration of theinternal cavity 74. The pump bulb 42 is cut off such that a portion ofeach of the third and fourth side segments 58 a, 58 b; the top segment50, and the second arc-shaped segment 57 is removed. The bottom segment52 is attached to the pump housing 40. In one embodiment, sixinterconnected side segments define the internal cavity 74. In oneembodiment, a thickness T2 of the top segment 50 is greater than athickness T1 of the third side segment 58 a. In one embodiment, athickness T3 of the second arc-shaped segment 57 is greater than thethickness T1. In one embodiment, the thickness T2 corresponds to thethickness T3. In one embodiment, a thickness of the bottom segment 52(thickness not indicated) corresponds to the thickness T2 of the topsegment 50. In one embodiment, a thickness of the first arc-shapedsegment 55 (thickness not indicated) corresponds to the thickness T3 ofthe second arc-shaped segment 57. Differentiating the thicknesses of theindividual segments can help adjust and control the resistance tocompression of the pump bulb 42 and thus facilitate controlling thetactile response to the user's thumb and finger, in turn helping toguide the user to engage and compress the correct external surfaces ofthe pump bulb 42.

FIG. 12 is a longitudinal cross-sectional view of one embodiment of apump 26 suitable for use with the penile prosthesis system 20 shown inFIG. 1 having a pump bulb 42. FIG. 12 further includes illustration ofthe valve assemblies of the pump housing 40.

In one embodiment, the pump housing 40 includes an inlet valve 140 thatcommunicates between the reservoir 22 (FIG. 1) and the pump bulb 42, anexhaust valve 142 that communicates between the pump bulb 42 and thecylinders 24, and a deflate valve 144 disposed in the pump housing 40transversely between the inlet valve 140 and the exhaust valve 142.

The inlet valve 140 includes a ball 150 that is biased into contact witha surface 152 by a spring 154. The ball 150 is configured to bedisplaced from the surface 152 (thus compressing the spring 154) whenliquid flows from the reservoir through the inlet tube 28 and into thepump bulb 42. When the liquid flow from the reservoir is reduced, ormore specifically, when the pressure driving the liquid flow from thereservoir is reduced, the spring 154 biases the ball 150 into contactwith the surface 152 to seat the ball 150 on the surface 152 and blockbackflow of the liquid from the bulb 102 back to the reservoir. In thismanner, the inlet valve 140 provides a one-way inlet valve.

The exhaust valve 142 includes a ball 160 that is biased into contactwith a surface 162 by a spring 164. The ball 160 is configured to bedisplaced from the surface 162 (thus compressing the spring 164) whenliquid flows from the pump bulb 42 through the exhaust valve 142 towardthe cylinders. For example, compressing the pump bulb 42 ejects liquidfrom the pump bulb 42, which unseats the ball 160 from the surface 162to allow the liquid to flow past the ball 160 and the deflate valve 144into the cylinders. Expansion (or recovery) of the pump bulb 42 drawsliquid from the reservoir, past the ball 160, and into the bulb 102. Thespring 164 biases the ball 160 into contact with the surface 162 toblock backflow of liquid from the cylinders into the pump bulb 42. Inthis manner, the exhaust valve 142 provides a one-way exhaust valve.

The deflate valve 144 is configured to allow liquid to flow from thereservoir 22 into the pump bulb 42 and out the pump bulb 42 into thecylinders 24 during inflation of the cylinders (FIG. 1) as describedabove. The deflate valve 144 is also configured to allow for the rapiddeflation of the cylinders 24. For example, in one embodiment pressingon the activation surface 168 moves the deflate valve 144 to the rightin the orientation of FIG. 10, which allows fluid to flow from thecylinders 24 axially along the deflate valve 144 directly back into thereservoir 22.

Suitable materials for fabricating the pump 26 include silicone,polymers such as urethanes, a blend of polymers with urethane,copolymers of urethane, or the like. In one exemplary fabricationprocess, one of the suitable materials identified above is moulded intothe shape of the pump bulb 42 illustrated in one of FIG. 1-6, 8 or 10.

FIG. 13 is a schematic view of a hand grasping the pump 26. The pump 26is sized to be implanted within the scrotum. However, the operation ofthe pump 26 and the improved grasping surfaces are best understood inisolation from the tissues of the body. The pump bulb 42 provides aconcave portion 58 a, 58 b defined between first and second end sections50, 52 and mid-section 54. The concave portion 58 a is configured toreceive the pad of the thumb, and another concave portion 58 b (notshown) is sized to receive the pad of a finger, such as, but not limitedto, an index finger. The first and second end section 50, 52 and themid-section 54 direct the thumb and the finger to the appropriateconcave portion 58, 58B and provide a structural exterior feature thatis easy to locate.

In one embodiment, the exterior surface of the pump 26 is smooth and theuser is allowed to grasp the pump bulb 42 by virtue of the concaveportions 58 a, 58 b in conjunction with the mid-section 54. In oneembodiment, the exterior surface of the pump bulb 42 is fabricated tohave increased wet sliding friction provided by a plurality of ribs, asaw tooth pattern, bumps, or other external surface feature added to theexterior surface.

FIG. 14 is a schematic view of the reservoir 22 implanted in an abdomenA and the pair of cylinders 24 implanted in a penis P with the pump 26intra-operatively connected to the reservoir 22 by the tubing 28 andconnected to the cylinders 24 by the tubing 30.

The reservoir 22 is suitable for implantation into the abdomen behindthe abdominal fascia, or in the space of Retzius, or another suitablelocation determined by the surgeon. The cylinders 24 are implanted intothe penis from a proximal location at the crus to a distal location atthe glans.

The pump 26 is implanted in the scrotum S in a manner that allows theuser to manually access both pump housing 40 and the pump bulb 42. Theconcave portions 58 a, 58 b (FIGS. 5, 10) in cooperation with the firstand second end sections 50, 52 and the mid-section 54 direct the user'sfinger and thumb to the external surface at the concave portions 58 a,58 b and into a position that allows for maximum compression of the bulb42. The concavity in combination with the mid-and end-sections provide apump bulb 42 that is easier to manually locate and subsequently squeezewhen inflating the cylinders 24 of the penile prosthetic.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

What is claimed is:
 1. A method of implanting a penile prosthetic intreating erectile dysfunction, the method comprising: providing a pumphaving a pump bulb including a first end section and a second endsection and a mid-section extending between the first end section andthe second end section, with the mid-section having a first face that isplanar in longitudinal cross-section and a second face that is concaveand arced in longitudinal cross-section; implanting an inflatable memberinto a penis; implanting a reservoir into an abdomen; intraoperativelycoupling the pump between the inflatable member and the reservoir; andimplanting the pump in a scrotum.
 2. A method of implanting a penileprosthetic in treating erectile dysfunction, the method comprising:providing a pump having a pump bulb including a first end section and asecond end section and a mid-section extending between the first endsection and the second end section, with the mid-section having a firstface that is planar in longitudinal cross-section, a second face that isconcave and arced in longitudinal cross-section, and a third face thatis concave and on an opposite side of the pump bulb from the first faceand arced in longitudinal cross-section; implanting an inflatable memberinto a penis; implanting a reservoir into an abdomen; intraoperativelycoupling the pump between the inflatable member and the reservoir; andimplanting the pump in a scrotum.
 3. A method of treating erectiledysfunction, the method comprising: providing a pump having a pump bulbincluding: a first end section and a second end section, each of thefirst end section and the second end section formed as a portion of asphere, a mid-section extending between the first end section and thesecond end section, with the mid-section planar in longitudinalcross-section and forming an arc in lateral cross-section, and a firstconcave portion being arced in longitudinal cross-section between afirst apex located in the first end section and a second apex located inthe second end section; implanting an inflatable member into a penis;implanting a reservoir into an abdomen; intraoperatively coupling thepump between the inflatable member and the reservoir; and implanting thepump in a scrotum.